GRADUATED ADAPTER WITH CLAVE


Device Classification Name

catheter, straight

510(k) Number K080007
Device Name GRADUATED ADAPTER WITH CLAVE
Applicant
ICU MEDICAL, INC
4455 atherton dr.
salt lake city, 
UT 
84123

Applicant Contact tracy best
Correspondent
ICU MEDICAL, INC
4455 atherton dr.
salt lake city, 
UT 
84123

Correspodent Contact tracy best
Regulation Number 876.5130
Classification Product Code
EZD  
Subsequent Product Code
KNY  
Date Received 01/02/2008
Decision Date 05/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No